# FDA The Food and Drug Administration regulates drugs, vaccines, medical devices, food, and tobacco — products touching an estimated quarter of U.S. consumer spending. It sits inside [[Department of Health and Human Services]] and is the regulatory chokepoint where [[Big Pharma]]'s money meets the state, which makes it the vault's premier case study in dual capture: long captured *by industry* (user fees fund a large share of its drug-review budget; commissioners like [[Scott Gottlieb]] exit straight to Pfizer's board), it is now being captured *against industry* by the [[MAHA]] movement. ## The MAHA-Era FDA Under [[Robert F. Kennedy Jr]]'s HHS, the FDA became an ideological battleground. Commissioner [[Marty Makary]] (2025–2026) and his vaccines chief Vinay Prasad announced in May 2025 that COVID-19 vaccines would be limited to people 65+ or at high risk, with new large trials demanded before approval for healthy younger adults — a sharp break with prior universal-recommendation policy. The agency lost thousands of staff to layoffs and resignations, suffered open feuds among its leadership, and faced accusations of politicization from both directions: too accommodating to Kennedy's vaccine skepticism for scientists, too slow on deregulation for industry. The tenure ended in a perfect symbol of the administration's priorities: Makary resigned in May 2026 rather than defend the administration's authorization of fruit-flavored vapes, which he opposed. He was replaced on an acting basis by **Kyle Diamantas** — a lawyer with no medical degree who had been running the foods division since February 2026. ## Why the FDA Matters Here - **Approval power is market power.** An FDA decision creates or destroys billions in value overnight — see [[Guardant Health]]'s Shield approval (2024) for how approval flows downstream into CMS coverage fights. - **The user-fee structure** (since 1992) makes the regulated industry the regulator's paying client — textbook [[Regulatory Capture]]. - **The revolving door spins both ways**: Gottlieb to Pfizer; [[Alex Azar]] through HHS twice; MAHA loyalists now flowing in as the counter-capture. - **[[Operation Warp Speed]]** showed what the agency can do under emergency authority — and seeded the backlash now running it. ## Connections - [[Department of Health and Human Services]] — Parent department - [[Marty Makary]] — Commissioner 2025–2026; resigned over flavored vapes - [[Robert F. Kennedy Jr]] / [[MAHA]] — The current ideological management - [[Scott Gottlieb]] — Commissioner 2017–2019; the industry-capture direction - [[Big Pharma]] / [[Regulatory Capture]] — The structural analysis